Benzonatate 200 mg/1
Benzonatate · CAPSULE · RedPharm Drug, Inc.
Benzonatate is a capsule containing benzonatate at 200 mg/1, taken oral. Manufactured by RedPharm Drug, Inc..
Key Facts
- Brand Name
- Benzonatate
- Generic Name
- Benzonatate
- NDC Code (Product)
67296-1751- Manufacturer
- RedPharm Drug, Inc.
- Strength
- 200 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206948
- Drug Class
- Non-narcotic Antitussive [EPC]
- Marketing Start
- 01/01/2020
Recall History
Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Calvin Scott & Company, Inc.
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Strides Pharma INC
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Zydus Pharmaceuticals USA Inc
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Amerisource Health Services LLC
Superpotent drug: Assay results were slightly above specification at the time zero point.
American Health Packaging
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Benzonatate Capsule is indicated for the symptomatic relief of cough.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Warnings
WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Contraindications
CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.
Adverse Reactions
ADVERSE REACTIONS Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm,cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation; headache; dizziness; mental confusion; visual hallucinations. GI: constipation; nausea; GI upset. Dermatologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.
Frequently Asked Questions
What is Benzonatate used for?
Benzonatate contains Benzonatate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Benzonatate a controlled substance?
Benzonatate is not classified as a controlled substance by the DEA.
What is the generic name for Benzonatate?
The generic name for Benzonatate is Benzonatate. There are 1 other brand versions of Benzonatate.
What is the NDC code for Benzonatate 200 mg/1?
The NDC (National Drug Code) for Benzonatate 200 mg/1 is 67296-1751, listed by RedPharm Drug, Inc..